Trial Outcomes & Findings for Accuracy of Robotically Assisted Cranial Biopsies (NCT NCT05891002)

Results Overview

Determine the percentage of patients with definitive pathological finding (histologically determined)

Recruitment status

TERMINATED

Target enrollment

4 participants

Primary outcome timeframe

Until study termination, approx. 21 months

Results posted on

2026-06-01

Participant Flow

4 patients could be recruited.

Inclusion and exclusion criteria were reviewed and enrolled patients consented.

Participant milestones

Participant milestones
Measure	Intervention Robotically assisted cranial biopsies using Cirq® Robotic Alignment Module Cranial and registering via Auto-Registration Software Universal AIR Cranial and Loop-X® Mobile Imaging Robot.
Overall Study STARTED	4
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=4 Participants Robotically assisted cranial biopsies using Cirq® Robotic Alignment Module Cranial and registering via Auto-Registration Software Universal AIR Cranial and Loop-X® Mobile Imaging Robot.
Age, Continuous	71 years n=4 Participants
Sex: Female, Male Female	2 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=4 Participants
Region of Enrollment France	4 Participants n=4 Participants

PRIMARY outcome

Timeframe: Until study termination, approx. 21 months

Population: 4 patients were enrolled to the intervention group. There was no control group. The primary endpoint was collected from 3/4 patients.

Determine the percentage of patients with definitive pathological finding (histologically determined)

Outcome measures

Outcome measures
Measure	Intervention n=3 Participants Robotically assisted cranial biopsies using Cirq® Robotic Alignment Module Cranial and registering via Auto-Registration Software Universal AIR Cranial and Loop-X® Mobile Imaging Robot.
Diagnostic Yield	100 % of pat. with definitive path. finding

SECONDARY outcome

Timeframe: Until study termination, approx. 21 months

Population: The accuracy of the location of the biopsy needle was not able to be assessed because the automatic registration procedure was not done with Loop-X® as per study protocol.

Determine accuracy of biopsy needle by comparing the target and entry point location to the planned location

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Intraoperative, up to 3 hours

Population: 4 patients were enrolled to the intervention group. There was no control group. The endpoint was collected from 3/4 patients.

Determine the time needed for the intraoperative biopsy procedure

Outcome measures

Outcome measures
Measure	Intervention n=3 Participants Robotically assisted cranial biopsies using Cirq® Robotic Alignment Module Cranial and registering via Auto-Registration Software Universal AIR Cranial and Loop-X® Mobile Imaging Robot.
Time for Procedure	82.5 minutes Standard Deviation 17.7

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Jean-Michel Lemee

Centre Hospitalier Univeristaire D'Angers

Phone: 02.41.35.38.93

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place